Jeff Francer Before FDA Transparency Task Force

Statement of Jeffrey K. Francer, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America at the Public Meeting of the FDA Transparency Task Force

June 24, 2009

Introduction

Good morning. I am Jeff Francer, Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA). We are pleased to provide input on the Food and Drug Administration’s (FDA) transparency initiative during today’s public meeting, and we intend to submit more extensive comments to the docket.

PhRMA is a voluntary, non-profit association that represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier and more productive lives. In 2008, PhRMA members invested approximately $50.3 billion to develop new medicines. Accordingly, PhRMA has a substantial interest in maintaining a strong and effective FDA that facilitates the development and approval of safe and effective innovative medicines.

PhRMA is highly supportive of the FDA’s transparency initiative, because transparency fosters accountability. It is for this reason that PhRMA’s Board of Directors recently voted unanimously to update and enhance our voluntary Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (Clinical Trial Principles). As a result of these revisions, companies following the PhRMA Clinical Trial Principles will enhance transparency about their clinical trials at the time of patient registration, upon new drug approvals, and – for the first time – upon the discontinuation of research programs. In short, the research-based pharmaceutical industry is working to increase the availability of information about one of the most significant stages of the research and development process: clinical trials in patients.

Improving FDA’s Existing Transparency

Before discussing the ways in which FDA can improve its openness and communications, it is important to acknowledge that the FDA is already one of the most transparent public health agencies in the world. It is hard to imagine any other similar government agency that provides on its web page all of its: approval letters, warning letters, advisory committee briefing materials, summary bases of approval, internal standard operating procedures, guidance documents, regulations, citizen petitions, as well as product-specific details on risk management programs and emerging safety information. In addition, under the Freedom of Information Act (FOIA), consumers are able to access manufacturing inspection reports, clinical trial inspection information, and even employee manuals.

Given the extraordinary amount of information available to the public – much of it online – it may be surprising that we are even participating in a meeting to improve openness. But we can all improve, and the FDA’s mission requires that we make sure that the agency is communicating to healthcare professionals and the public as effectively as possible.

PhRMA believes that the FDA can do even more to explain its approval decisions and other important regulatory actions to healthcare professionals and to patients. Put simply, FDA should make it obvious, to those who are interested, how scientific data leads to its approval decisions. For example, when the FDA makes a regulatory decision following a public expert advisory committee, the FDA should explain how the committee’s recommendation factored into its decision. In addition, FDA should consider a prominent link from its home page that explains the drug approval process in consumer-friendly language. This presentation could include links to resources both before approval (e.g., ClinicalTrials.gov) and after approval (e.g., links to approval materials or inspection information). Such a presentation could demonstrate to the public the enormous amount of data that FDA reviews in the approval process and thereafter. We intend to expand upon these and other ideas in more detailed comments for the docket.

Maintaining Innovation

As I have indicated, PhRMA supports FDA’s initiative to improve openness and communication about operations and its review of medical products. At the same time, it is critical to balance increased transparency with the need to encourage biopharmaceutical manufacturers to develop important medical advances in a competitive manner. Simply put, increased disclosure requirements that fail to protect innovative research and development will harm, rather than help improve, the public health.

For decades, Congress and the FDA have recognized the importance of protecting proprietary pre-approval information about medical products from inappropriate premature disclosure through FOIA and the Trade Secrets Act. Companies large and small invest billions of dollars to investigate and develop a new medicine. If FDA disclosed valuable confidential information about such a product before it is approved for marketing – thereby allowing both domestic and foreign competitors to glean otherwise unavailable insights into the development process – the government would markedly decrease the incentive for development in the first place. This was the reasoning of the FDA 35 years ago when the agency drafted the final provisions of its FOIA regulations, and the rationale is just as valid today.

Conclusion

In conclusion, PhRMA appreciates the opportunity to provide input on FDA’s transparency initiative. PhRMA and its member companies are firmly committed to helping FDA enhance its openness and communications. At the same time, it is critical that the government continue to act as a responsible steward of confidential commercial information and trade secrets in order to maintain the competitive market for innovations that save lives.